Mr. Matthew r. Smith, senior trial and a consultant to Amgen, said researcher that the results are significant because no prior drug had been proven to prevent the spread of cancer to the bone, causes pain and disability among men who have prostate cancer.
"This study is the first to demonstrate the prevention of bone metastases, the most devastating complication of cancer of the prostate," Dr. Smith, associate professor at the Faculty of medicine at Harvard and the Massachusetts General Hospital, said in an e-mail. "It deals with a critical unmet need".
Results surprised Wall Street, which has generally been betting that the trial would not show a positive result. The Amgen shares rose more than 7% after hours.
"Who says miracles do Happen in biotechnology" was the title on a ticket issued Monday by Yaron Werber, an analyst at Citigroup.
But Mark Schoenebaum, the ISI Group analyst said in a note that the results were "at the lower end of what might be considered clinically significant." He also said that the absence of a provision of survival is probably "generate a debate".
The trial involved 1,432 so-called men resistant to castration prostate cancer who randomly assigned to receive injections every four weeks of denosumab or placebo. Cancer had not spread to the bone at the beginning of the trial, but was seen as a potential high because P.S.A. men, markers of the severity of the disease, increased.
The goal was to see if denosumab may delay the time until the cancer spread to the bones or the patient died from any other cause. Drug delayed median time to do a month 4.2, a statistically significant difference. Using a different statistic, the risk of bone metastases or death was reduced by 15 per cent.
Major side effects were low in calcium in the blood and the jaw bones associated with many drugs bone destruction.
The results were announced by press release, so that they have not been reviewed by independent experts. Amgen provides more details, saying that it would submit to a medical meeting.
The advantage is entirely from delay bone metastases, not death. Mr. Roger M. Perlmutter, Executive Vice President of research and development at Amgen, said the trial expected to show a benefit of survival since most patients lived during the trial. Also, men who have experienced the bone metastases have been removed from study so that they could be treated with a drug that helps to prevent fractures.
Denosumab blocks a protein involved in the destruction of the bone. That is without doubt the bone less welcoming surroundings for cancer to take root cells.
The drug sold under the name of Xgeva, was approved in November to help prevent fractures and other skeletal problems after prostate and other cancers were already spread to the bone. The drug is also sold to treat osteoporosis as Prolia.
Amgen, the largest company of biotechnology in the world has suffered from the decline in sales of its drug Aranesp anaemia due to security issues. Growth in sales of some of his other drugs slowing down that denosumab is regarded as a key to its future. Use in the prevention of bone metastases may add several hundreds of millions of dollars annually in the annual turnover of denosumab.
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